Methods For Weight Loss And Ketogenic Compositions

ABSTRACT

The present disclosure relates to a weight-loss composition including protein and fat and methods of use. The weight loss composition is substantially free of carbohydrates. The composition induces body weight loss when administered to a subject as the only source of nutrition for at least 12 hours.

RELATED APPLICATIONS

This application is a Divisional of U.S. application Ser. No.13/589,820, filed on Aug. 20, 2012, which is a continuation-in-partapplication of U.S. application Ser. No. 13/466,372, filed May 8, 2012,which claims priority to U.S. Provisional Application No. 61/525,581,filed Aug. 19, 2011, and is a Continuation of PCT InternationalApplication No. PCT/US12/51448, filed Aug. 17, 2012. The disclosures ofthese applications including the specifications, the drawings, and theclaims are hereby incorporated by reference in their entirety. Field

The present disclosure provides a weight loss composition and method.More specifically, the weight loss composition of the subject technologyincludes protein and fat, but is substantially free of carbohydrates.

BACKGROUND

The current way of life in most urbanized societies may be characterizedby less physical work and increased consumption of fat, carbohydratesand proteins, resulting in the energy intake exceeding energyexpenditure. This shift in the energy balance causes storage of energyin the body in the form of fat, leading to an increase of overweight andobesity, due to the long-term energy imbalance associated withlifestyle.

The percentage of overweight people increases year by year and obesityis a disease that is reaching epidemic proportions in some countries.The health risks associated with being overweight and obesity arenumerous and it has been shown that these conditions contribute tomorbidity and mortality of individuals suffering from diseases such ashypertension, stroke, diabetes mellitus type II, gallbladder disease andischemic heart disease. The cosmetic perspective of body fat is also tobe considered as the demand for dietary supplements or medicine to gainor maintain a leaner body is constantly increasing.

The pharmaceutical industry has developed drugs to help people loseweight. However, no drug has been discovered that allows individuals toeat all they desire and retain a sedentary lifestyle whilesimultaneously losing weight. Furthermore, the drug products availableto the general public, whether by prescription or as over-the-counterpreparations, are not free of risk. Known risks include valvular heartdisease arising out of the use of the combination of fenfluramine andphentermine (Fen-Phen), and irregular heart beat (arrhythmia) that isassociated with the use of phenylpropanolamine (PPA). These risks haveresulted in bans on the use of these drugs in weight loss products andprograms in some countries.

Health risks of anti-obesity preparations are not limited toprescription and/or over-the-counter medications. The use of ephedra innutritional products employed for weight loss has been associated witharrhythmia and even sudden death in susceptible individuals.

A common strategy for reducing weight or for maintaining a normal bodyweight has been to reduce the average energy intake by lowering thedietary fat intake. However, the low- or non-fat and other diet productsare far too often abandoned by the individual due to a reduced tastesensation, palatability and/or structure. To increase patient adherenceto a non-fat diet regimen and promote a rapid weight loss, for example,a diet regimen termed “NEC” (Nutrizione Enterale Chetogena)—also knownas “KEN” (Ketogenic Enteral Nutrition), or Dieta al Sondino, which inthe U.S. is being marketed as “DietTube®”—has been devised whichinvolves a nasogastric administration of a solution containingpredominantly protein for a predefined period of about 10 days.

However, although the tube feeding of the diet composition in the NEC,KEN or DietTube® diet systems has been successful in inducing weightloss, still a significant portion of the patients using these or similardiets report being hungry. Therefore, there is still a need for aweight-loss product and method having the ability of reducing orpostponing the sensation of hunger and/or appetite and perhaps at thesame time being able to increase or prolong the feeling of satiety.

SUMMARY

In the subject technology, it has been found that the addition of aneffective amount of fat to protein at certain ratios in a compositionfor nasogastric administration, is surprisingly effective in bothinducing a rapid weight loss and significantly reducing or eliminatinghunger.

The subject technology is illustrated, for example, according to variousaspects described below.

In one aspect, the subject technology relates to a weight-losscomposition including protein and fat; wherein the composition issubstantially free of carbohydrates; and wherein the composition inducesbody weight loss when administered to a subject as the only source ofnutrition for at least 12 hours. In an embodiment relating to thisaspect, the fat comprises medium chain triglycerides (MCT) that issubstantially free of long chain triglycerides (LCT) and/or small chaintriglycerides (SCT); and the ratio of the MCT to the protein in thecomposition is in the range of about 0.05:1 to about 1:1 by weight, andthis ratio synergistically reduces or eliminates hunger or inducessatiety in the subject for a period of at least 12 hours. In anotherembodiment relating to this aspect, the composition induces an averagebody weight loss of greater than or equal to about 1% per day. In anembodiment relating to this aspect, the fat comprises LCT or SCT that issubstantially free of the other two forms of triglycerides (i.e., MCTand SCT or MCT and LCT, respectively); and the ratio of the LCT or SCTto the protein in the composition is in the range of about 0.05:1 toabout 1:1 by weight, and this ratio synergistically reduces oreliminates hunger or induces satiety in the subject for a period of atleast 12 hours. In another embodiment relating to this aspect, thecomposition induces an average body weight loss of greater than or equalto about 1% per day.

In another aspect, the subject technology relates to a method ofinducing body weight loss in a subject in need thereof, includingadministering to the subject a weight-loss composition comprising aneffective amount of protein and an effective amount of fat, wherein thecomposition is substantially free of carbohydrates; and wherein thecomposition induces body weight loss in the subject when administered tothe subject as the sole source of nutrition for a period of at least 12hours. In an embodiment relating to this aspect of the subjecttechnology, the fat comprises medium chain triglycerides (MCT) that issubstantially free of long chain triglycerides (LCT) and/or small chaintriglycerides (SCT); and the ratio of the MCT to the protein in thecomposition is in the range of about 0.05:1 to about 1:1 by weight, andthis ratio synergistically reduces or eliminates hunger or inducessatiety in the subject for a period of at least 12 hours. In anotherembodiment relating to this aspect, the method induces an average bodyweight loss of greater than or equal to about 1% per day. In anembodiment relating to this aspect, the fat comprises LCT or SCT that issubstantially free of the other two forms of triglycerides (i.e., MCTand SCT or MCT and LCT, respectively); and the ratio of the LCT or SCTto the protein in the composition is in the range of about 0.05:1 toabout 1:1 by weight, and this ratio synergistically reduces oreliminates hunger or induces satiety in the subject for a period of atleast 12 hours. In another embodiment relating to this aspect, thecomposition induces an average body weight loss of greater than or equalto about 1% per day.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andclaims hereof.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology asclaimed.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. It willbe apparent, however, to one ordinarily skilled in the art that thesubject technology may be practiced without some of these specificdetails. In other instances, well-known structures and techniques havenot been shown in detail so as not to obscure the subject technology.

The subject technology is predicated, at least in part, on thesurprising finding that addition of an effective amount of fat (e.g.,medium chain triglycerides (MCT)) to a predominantly protein diet fornasogastric administration not only does not reduce the effectiveness ofthe diet in reducing body weight, but also can promote a comparable oreven greater body weight loss as compared to a diet that lacks fat orhas a negligible amount of fat.

In addition, the subject technology is predicated, at least in part, onthe surprisingly finding that in weight loss compositions of the instantdisclosure, at certain ratios, the fat and protein can synergisticallyreduce and/or eliminate hunger in a subject to whom the composition isbeing administered.

Accordingly, in an aspect, the subject technology relates to a weightloss composition that includes protein and fat; wherein the compositionis substantially free of carbohydrates; and wherein the compositioninduces body weight loss when administered to a subject as the onlysource of nutrition for at least 12 hours.

In another aspect, the subject technology relates to a method ofinducing body weight loss in a mammal such as human, the method includesadministering to a subject a weight-loss composition containing aneffective amount of a protein and an effective amount of fat. Thecomposition in this aspect is substantially free of carbohydrates. Inaddition, the composition induces body weight loss in the subject whenadministered to the subject as the sole source of nutrition for a periodof at least 12 hours.

In certain embodiments, the weight loss composition of the subjecttechnology is administered nasogastrically via a feeding tube. Incertain embodiments, the weight loss composition of the subjecttechnology is administered continuously throughout the treatment period.The treatment period may be any period from about 1 hour to 14 days. Inother embodiments, the weight loss composition of the subject technologyis administered intermittently, for example, every 1 to 24 hours, or anyintervals in between, during the treatment period.

Both components (i.e., protein and fat) may be administeredsimultaneously, or they may be administered separately during thetreatment period. In this embodiment, the fat may be administered as anoil, for example, while the protein may be administered as an aqueoussolution. In certain embodiments, when the two components areadministered separately, protein, for example, can be administeredcontinuously while MCT is administered intermittently and in bolus every1 to 24 hours, or vice versa.

A phrase such as “an aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples of the disclosure. A phrasesuch as “an aspect” may refer to one or more aspects and vice versa. Aphrase such as “an embodiment” does not imply that such embodiment isessential to the subject technology or that such embodiment applies toall configurations of the subject technology. A disclosure relating toan embodiment may apply to all embodiments, or one or more embodiments.An embodiment may provide one or more examples of the disclosure. Aphrase such “an embodiment” may refer to one or more embodiments andvice versa.

As stated above, the weight loss composition of the present disclosureis substantially free of carbohydrates. In this context, the term“substantially free of carbohydrates” means that the compositioncontains less than about 1.5% by weight of carbohydrates, including zeropercent by weight of such ingredient. With respect to the triglyceridesdisclosed herein, the term “substantially free of” in the context oflong chain, medium chain and/or small chain triglycerides means that thecomposition contains less than about 0.05% by weight of the specifiedtriglycerides, including zero percent by weight of such ingredient.

As used herein, the term “fat” refers to triacylglycerides ortriglycerides formed by the esterification reaction of long chain-,medium chain- or short chain-fatty acids with glycerol, a trihydroxyalcohol, or a mixture thereof, in any of solid, liquid or suspensionforms, regardless of whether they are obtained from animal, fowl, fishor plants sources or are made synthetically, so long as they are safefor consumption by mammals, particularly humans. The fatty acid chainsin biological systems usually contain an even number of carbon atoms,typically between 14 and 24, with the 16 (palmitate) and 18 (stearate)carbon fatty acids being the most common. Generally, triglyceridescomprised of fatty acid chains with from 2 to 5 carbon atoms arereferred to as short chain triglycerides (“SCT”) and those with from 6to 12 carbon atoms are referred to as medium chain triglycerides(“MCT”). Both SCT and MCT are often saturated and are found in dairyproducts as well as some plant oils. Those triglycerides comprised offatty acid chains with 14 carbon atoms or greater are referred to aslong chain triglycerides (“LCT”), may have points of unsaturation andare found in animal, fowl and fish products as well as plant oils.

In the context of the present disclosure, hunger is convenientlyassessed by using a variation of visual analogue scales (VAS) asdescribed in Flint et al. “Reproducibility, power and validity of visualanalogue scares in assessment of appetite sensations in single test mealstudies.” Int. J. Obesity 24(1): 38-48 (2000), which is incorporatedherein by reference its entirety. A scale of 0-4 (with zero being not atall hungry and 4 being as hungry as the subject has ever felt) was usedto assess hunger in subjects using the composition and methods of thepresent disclosure.

As used herein, the phrase “the sole source of nutrition” refers to thecomposition of the subject technology being the only food a subjectconsumes during the treatment period. The subject may still consumewater and unsweetened beverages, free of carbohydrates, to quenchthirst; however no other food or nutrient should be consumed during thetreatment period.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe subject technology. All structural and functional equivalents to theelements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology.

Generally, weight gain is caused by consuming more calories than thebody uses for its basal metabolic functions and additional activities inwhich an individual is involved. The human body stores these excesscalories as fatty deposits (lipids in adipose tissue) throughout thebody, but is not able to readily access these fatty deposits to satisfyenergy needs. To use these stored lipids as an energy source, the numberof calories ingested must be less than the total energy expenditure ofthe body (basal metabolic rate plus activity level). Under hypocaloricconditions the body consumes stored fat as a source of fuel.

Thus, a common practice for weight loss has been to limit fat andcarbohydrate intake. However, a reduced fat and carbohydrate diet isusually unpalatable and unappetizing and induces further cravings forfood that reduce adherence to weight loss regimens. As mentioned above,diet regimens such as NEC, KEN or DietTube® diets have been designed todeliver a predominantly protein diet directly to the stomach to overcomethe palatability problems associated with such diets. However, suchdiets have not been able to totally eliminate hunger and cravings forfood in patients using these regimens. Consequently, these diets oftenfail.

In the subject technology, however, it has surprisingly been found thata combination of fat and proteins administered, which is substantiallyfree of carbohydrates, can synergistically act in reducing and/oreliminating hunger and promoting and/or prolonging satiety in subjectsfor at least 12 hours.

In addition, it has surprisingly been found that in the absence of thefat and protein in the compositions of the instant technology cansynergistically induce ketosis in subjects, which results in more weightloss as compared with a composition that has no or a negligible amountof fat such as that in NEC, KEN or DietTube® diets.

Accordingly, the subject technology relates to a composition and methodfor the management of body weight. In the present context the term“management of body weight” covers all aspects of modulating the bodyweight for maintenance or achievement of a “desirable weight.” Incontrast to the “desirable weight” the expressions “overweight” and“obesity” are used as indications of a body with a weight exceeding the“desirable weight.”

The “desirable weight”, “normal weight” or “optimal weight” for humansmay be defined according to standards such as Body Mass Index (BMI),which is a common measure expressing the relationship (or ratio) ofweight-to-height (for definition see below). The BMI is more highlycorrelated with body fat than any other simple measure of height andweight. Desirable BMI levels may vary with age, but a “normal” BMI isconsidered to be in the range of 18.5-24.9.

The definition of “overweight” is an increased body weight in relationto height, when compared to a standard of acceptable or desirableweight. Individuals with BMI in the range of 25-29.9 are considered tobe overweight.

Obesity is a multi-factorial disease involving an accumulation of excessadipose tissue (fat) sufficient to harm health. Obesity can cause thedevelopment of several diseases, and individuals who are significantlyoverweight or obese generally have a poor health status. Obesity islargely preventable through changes in lifestyle, especially diet.However, treatment may be desired and needed to aid in loosing ofweight.

There are many types of obesity, but it is most commonly assessed by asingle measure, the Body Mass Index (BMI) a ratio of weight and height(BMweight (kg)/height (m)²). The World Health Organization classifiesunderweight, normal weight, overweight and obesity according tocategories of BMI (cf. table below). This height independent measure ofweight allows comparisons to be made more readily within and betweenpopulations. The BMI value, however, neither distinguish fat from leantissue nor identify whether the fat is laid down in particular sitese.g., abdominally where it has more serious consequences. See Table 1.

Waist circumference measurement is also increasingly recognized as asimple means of identifying abdominal obesity. Body fat distribution canbe estimated by skinfold measures, waist-to-hip circumference ratios, ortechniques such as ultrasound, computed tomography, or magneticresonance imaging.

TABLE 1 Risk of co- Classification BMI (kg/m²) morbidities Underweight<18.5 Low (but risk of other clinical problems increased) Normal range18.5-24.9 Average Overweight* ≧25 Pre-obese 25.0-29.9 Mildly increasedObese >30.0 Class I 30.0-34.9 Moderate Class II 35.0-39.9 Severe ClassIII >40.0 Very Severe *The term overweight refers to a BMI ≧25, but isfrequently and also in the present specification and claims adapted torefer to the BMI 25-29.9, differentiating the pre-obese from the obesecategories

As illustrated in Table 1 above, the severities of obesity may byclassified by ranges of BMI where BMI in the range of 30-34.9 isclassified as moderate obesity, BMI in the range of 35-39.9 isclassified as severe obesity and BMI over 40 is classified as verysevere obesity. The definition of obesity may also include taking intoaccount both the distribution of fat throughout the body and the size ofthe adipose tissue deposits.

Individuals falling under the above characterization as “obese” are farmore susceptible to health implications as a consequence of theiroverweight. Several serious medical conditions have been linked toobesity, including type 2 diabetes, heart disease, high blood pressure,and stroke. Obesity is also linked to higher rates of certain types ofcancer. Obese men are more likely than non-obese men to die from cancerof the colon, rectum, or prostate. Obese women are more likely thannon-obese women to die from cancer of the gallbladder, breast, uterus,cervix, or ovaries. Other diseases and health problems linked to obesityinclude gallbladder disease and gallstones, liver disease,osteoarthritis, a disease in which the joints deteriorate possibly as aresult of excess weight on the joints, gout, another disease affectingthe joints, pulmonary (breathing) problems, including sleep apnea inwhich a person can stop breathing for a short time during sleep,reproductive problems in women, including menstrual irregularities andinfertility. Health care providers generally agree that the more obese aperson is the more likely he or she is to develop health problems.

The expression “cosmetic overweight” refers to a weight that does nothave any immediately medical implications on the individual but may bein a range that is not satisfactory for cosmetic reasons. As fashionwith respect to body size changes some individuals may interpret the“normal weight” as “cosmetic overweight.” As a consequence suchindividuals may have a desire for treating cosmetic overweight.

The subject technology provides compositions and methods for weightloss, the management of body weight, and the maintenance or achievementof a desirable weight in a subject in need thereof. In addition, thecompositions and methods of the subject technology can be used to treatphysical, physiological or psychological diseases or conditionsassociated with obesity and/or excess body weight.

In one aspect, the weight loss composition of the subject technologyprovides a ketogenic diet for the treatment of obesity and/or for weightmanagement. The ketogenic diet includes protein and fat, and issubstantially free of carbohydrates. The ketogenic diet (also known asthe K-E diet) can be used for complete nourishment of a subject for atleast 12 hours, without significant concomitant hunger and foodcravings. In an embodiment relating to this aspect, the weight losscomposition of the subject technology may have use for the treatment ofconditions or diseases (e.g., diabetes, metabolic syndrome orhypertriglyceridaemia) for which a ketogenic diet is beneficial.

The weight loss formulations of the subject technology are especiallysuitable for inducing rapid weight loss in a subject in need thereof. Incertain embodiments, the weight loss composition of the subjecttechnology is in dry form but is reconstituted in an aqueous solutionprior to nasogastric administration. In certain other embodiments, theweight loss composition of the subject technology can be administeredorally (e.g., by ingestion or orogastrically). Components such asvitamins, minerals, diluents or carriers may also be present in thecomposition of the subject technology. Accordingly, the compositions ofthe subject technology may include one or more pharmaceuticallyacceptable carrier(s), diluents(s) and/or excipient(s). The carrier,diluent and/or excipient must be “acceptable” in the sense of beingcompatible with the other ingredients of the composition and notdeleterious to the recipient thereof.

As used herein, and discussed elsewhere herein, proteins suitable foruse in the compositions and methods of the subject technology include,but are not limited to, intact or hydrolyzed whey protein, egg proteinincluding egg albumen, lactalbumin, casein, soy protein polypeptides orpeptides or amino acids (PPAA) and their derivatives from variousbiological sources, and are substantially free of carbohydrates. Incertain embodiments, the compositions of the subject technology includea single type of protein. In other embodiments, the protein content ofthe compositions of the subject technology can include more than type ofprotein or can include a mixture of two or more different proteins, eachof which can independently exist in an intact or hydrolyzed form orboth.

Whey protein comprises a protein fraction obtained from the milk ofcows. Cow milk contains two major protein fractions, including casein,which comprises about 80% of the total protein, and whey protein, whichcomprises about 20% of the total protein. Whey protein includes severalproteins, including, for example, β-lactoglobulin, α-lactoglobulin,immunoglobulins, and lactoferrin. Whey protein is more soluble thancasein and also has a higher quality rating.

Whey protein is available as “whey protein concentrate”, which containsabout 29% to 85% whey protein, and “whey protein isolate”, whichcontains 90% or more whey protein and little, if any, fat, cholesterol,or carbohydrates (e.g., Lactose). Regardless of the source of wheyprotein, the final concentration of whey protein in powder or liquidforms is about 25% to 99%. In an embodiment, the compositions of thesubject technology comprise whey protein isolate.

Whey protein contains essential and semi-essential amino acids,including cationic amino acids (e.g., Lysine, Arginine, and Histidine)and proteins and, therefore, is a high nutritional quality source ofprotein. Proteins of high nutritional value may be defined as proteinsthat contain high concentrations of essential and semi-essential aminoacids, including hydrophobic amino acids (Leucine, Isoleucine,Methionine, Phenylalanine, Tryptophan, Valine), hydroxylated amino acids(Threonine) and hydrophilic amino acids that are positively charged(Lysine, Arginine, and Histidine). Whey protein also has a very highbiological value, which is a measure of percent assimilation into thebody. It can be a particularly valuable source of high-value nutritionfor athletes and for individuals with special medical needs (e.g.,lactose intolerant individuals), and can be a valuable component of dietprograms. Further, whey protein contains biologically active proteinssuch as immunoglobulins and lactoferrin and, therefore, providesadvantages over other protein sources such as soy protein. Whey proteinalso has a fresh, neutral taste.

Egg protein also contains essential and semi-essential amino acids,including cationic (basic) amino acids and proteins and, therefore, is ahigh nutritional quality source of protein. Egg protein also has a veryhigh biological value, and thus may be found in various embodiments ofhigh protein compositions and dietary supplements.

In an embodiment, the effective amount of a protein used in compositionsand methods of the subject technology is an amount that together withfat induces weight loss in a subject. As discussed herein above, sucheffective amount of the protein can be determined in light of disclosedblood ketone levels, urine ketone levels or weigh loss measurements(e.g., BMI or body weight measurements before and after the treatment).In certain embodiments, the ratio of fat to protein in the compositionsof the subject technology is in the range of about 0.05:1 to about 1:1by weight. In this context, the daily (24-hour) protein dose is about1.0 g/kg/day to about 3.0 g/kg/day. Alternatively, the daily proteindose can be in the range of about 1.3 g/kg/day to about 2.5 g/kg/day ofprotein. In certain embodiments, a daily (24-hour) dose of thecomposition of the subject technology, for nasogastric administration,includes one or more proteins in a total amount of about 100 to about150 grams, or any specific number within that range. In certainembodiments, the daily dose of protein is about 108-135 grams, or anyspecific number within that range. In certain other embodiments, thedaily dose of protein is at least about 1 g/kg/day, at least about 1.5g/kg/day, at least about 2 g/kg/day, at least about 2.5 g/kg/day, atleast about 3 g/kg/day, at least about 4 g/kg/day, at least about 5g/kg/day, at least about 10 g/kg/day, at least about 15 g/kg/day, atleast about 20 g/kg/day, at least about 30 g/kg/day, at least about 40g/kg/day, or at least about 50 g/kg/day.

In an embodiment, the effective amount of protein for use incompositions and methods of the subject technology is an amount thattogether with fat of the composition synergistically induces ketosis andin turn weight loss in a subject. Ketosis and weight loss occur when theinstant composition is the sole source of nutrition for at least 12hours. In a related embodiment, the composition further reduces oreliminates hunger for at least 12 hours. As discussed herein above, sucheffective amount of a protein can be determined in light of blood ketonelevels, urine ketone levels or weigh loss measurements.

In an embodiment, the effective amount of a protein for use incompositions and methods of the subject technology is an amount thattogether with fat of the composition synergistically reduces oreliminates hunger in a subject. This synergy occurs when the compositionis administered to a subject as the only source of nutrition for atleast 12 hours. As discussed herein above, such effective amount of aprotein can be determined in light of hunger assessments using visualanalogue scales (VAS) as described in Flint et al. (2000) or a variationthereof.

In an embodiment, the weight loss composition of the subject technologyincludes an amount of protein, which can be at least, greater than,equal to, or any number in between 5%, 10%, 15%, 20%, 25%, 30%, 35%,40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95% w/w or w/vprotein). In another embodiment, the weight loss composition of thesubject technology provides a daily dosage of protein in an amount ofabout 100 to 150 grams. Alternatively, the weight loss composition ofthe subject technology provides a daily dosage of protein in an amountequal to or greater than 60 grams, 80 grams, 100 grams, 110 grams, 120grams, 130 grams, 140 grams or 150 grams, or any number in between. Inan embodiment, the weight loss composition of the subject technologyprovides a daily dosage of protein in an amount of about 108-135 grams.

As used herein, and discussed elsewhere herein, the fat suitable for usein the compositions and methods of the subject technology include longchain triglycerides (LCT), short chain triglycerides (SCT) and/or mediumchain triglycerides (MCT). The fat component can be any triglycerides(in liquid form (e.g., oil), solid form (e.g., fat or powder), orsuspension) known in the art to be suitable for use in nutritionalcompositions. Typical fats include those from animal or plant sourcessuch as, for example, milk fat, safflower oil, canola oil, egg yolklipid, olive oil, cotton seed oil, coconut oil, hazelnut oil, palm oil,palm kernel oil, and/or rapeseed oil. The fat may consist of saturated,unsaturated, mono-, di-, tri- or polyunsaturated fatty acids.Unsaturated fatty acids may be n-3 or n-6 fatty acids. In certainembodiments, the fat component contains primarily or solely one form offat, i.e., MCT, LCT or SCT.

The short chain triglycerides suitable for use in the subject technologyare preferably those comprising from 2 to 5 carbon atoms, which may beeither saturated or unsaturated, straight or branched. They may bederived from any synthetic or natural organic acid, including, but notlimited to butyric (butanoic), valeric (pentanoic),glycolic(hydroxyacetic), lactic (2hydroxypropanoic), hydracrylic(3-hydroxypropanoic), hydroxybutyric, hydroxypentanoic and the likeacids As used herein, chemical names include isomeric variations: forexample, “butyric acid” includes normal butyric acid (butanoic) andiso-butyric (2methylbutanoic acid), “valeric acid” includes normalvaleric acid and iso-valeric (3methylbutanoic) as so forth. Thepreferred fatty acids are butyric or mixtures of these.

Mixtures of short chain fatty acids may be derived from unhydrogenated,partially hydrogenated or fully hydrogenated dairy butterfat, coconut,palm kernel and the like oils.

The medium chain residues are preferably those comprising from 6 to 14carbon atoms, more preferably from 6 to 10 carbon atoms and mostpreferably from 8 to 10 carbon atoms. They include, but are not limitedto, C6 (caproic acid), C8 (caprylic acid), C10 (capric acid) and C12(lauric acid) as well as mixtures thereof. The most preferred mediumchain fatty chain comprises lipoic or thioctic acid in any one of itsforms including alpha-lipoic acid.

The long chain residues may de derived from any synthetic or natural,straight or branched, saturated or unsaturated, organic acid including,but no limited to paimitic (hexadecanoic), stearic (octadecanoic),arachidic (eicosanoic), behenic (docsanoic), lignoceric (tetracosanoic),cerotic (hexacosanoic), montanic (octacosanoic), melissic (triaconanoic)and the like acids. They may also be derived by hydrogenating anunsaturated acid, including, but not limited to palmitoleic(9-hexadecenoic), oleic (cis 9octadecenoic), elaidic(trans-9-octadecenoic), vaccenic (trans-11-octadecenoic), linoleic (cis,cis-9,12-octadecenoic), linolenic (9,12,15-octadecatrienoic and6,9,12octadecatrienoic), eleostearic (9,11,13 -octadecatrienoic),arachidonic (5,8,11,14eicosatetraenoic), nervonic(cis-15-tetracosenoic), eicosapentanoic, docosatetraenoic,docosapentaenoic, docosahexaenoic, and the like acids. Chemical namesinclude isomeric variations.

The long chain residues may be derived from, for example,non-hydrogenated, partially hydrogenated or fully hydrogenated oils suchas soybean, safflower, sunflower, high oleic sunflower, sesame, peanut,corn, olive, rice bran, babassu nut, palm, mustard seed, cottonseed,poppyseed, low or high erucic rapeseed, shea, marine, meadowfoam, andthe like oils. Alternatively, the long chain residues may be derivedfrom tallow, lard, shea butter, dairy butter, jojoba and mixturesthereof. Suitable long chain (C14-C22) triglycerides for use in thesubject technology include, but are not limited to, arachis oil, soyabean oil, castor oil, corn oil, safflower oil, olive oil, apricot kerneloil, sesame oil, cotton seed oil, sunflower seed oil, palm oil andrapeseed oil.

In an embodiment, the fat suitable for use in the subject technologycomprise one or more omega-3 polyunsaturated fatty acids (“omega-3PUFA's) or derivatives thereof. The omega-3 PUFAs (C18:3n3) for usewithin the composition of the subject technology are selected fromalpha-linolenic acid, EPA and DHA in the form of, inter alia, fattyacids, triglycerides, phospholipids, esters or free fatty acid salts.

In one embodiment of the subject technology, the omega-3 PUFAs may beextracted from zooplankton, fish or other marine animals using suitablebioconcentration techniques. In the alternative, omega-3 PUFAs may besynthesized using microalgae as the source material. In one preferredform, marine fish oil may be mixed directly with SCT and MCT componentsto form fat mixture suitable for use in the subject technology. Themarine oil may be extracted by techniques known in the art from, interalia: finfish such as cod, salmon, tuna, herring, halibut, shark,catfish, pollock, dogfish, anchovy, mackerel, trout, and eel; animalssuch as seals and whales; crustaceans such as crabs, clams and lobster;mollusks and the like.

Without limiting the generality of the foregoing, the preferred marinesources of omega-3 PUFAs are as follows: salmon (sockeye), tuna, salmon(pink), shark, dogfish, halibut, anchovy, salmon (Atlantic), mackerel(Atlantic), salmon (Pacific), spanish sardine, trout (rainbow), mackerel(Pacific), and swordfish (herring). Alternatively, plant sources ofomega-3 PUFAs may be used. The great advantage of plant sources may bereduced odour as compared to some marine sources. Plant sources include,but are not limited to, plant oils such as hemp oil, flaxseed oillinseed oil and corn oil as well as soy. The most preferredplant-derived sources are flax seed oil and linseed oil.

Suitable medium chain triglycerides (MCTs) for use in the subjecttechnology include but are not limited to, MCTs represented by thefollowing formula:

wherein R1, R2, and R3 are independently selected from the groupconsisting of a fatty acid residue esterified to a glycerol backbonehaving 6-12 carbons in the carbon backbone (C₆ to C₁₂ fatty acids), asaturated fatty acid residue esterified to a glycerol backbone having6-12 carbons in the carbon backbone (C₆ to C₁₂ fatty acids), anunsaturated fatty acid residue esterified to a glycerol backbone having6-12 carbons in the carbon backbone (C₆ to C₁₂ fatty acids), andderivatives of any of the foregoing. The structured lipids of thissubject technology may be prepared by any process known in the art, suchas direct esterification, rearrangement, fractionation,transesterification, or the like. For example the lipids may be preparedby the rearrangement of a vegetable oil such as coconut oil. ExemplaryMCTs include caproic triglyceride, caprylic triglyceride, caprictriglyceride, myristic triglyceride or lauric triglyceride, which can beextracted or derived from plant sources such as, for example, coconutoil or palm kernels.

In an embodiment, the compositions and methods of the subject technologycomprise the use of MCT wherein R1, R2, and R3 are fatty acidscontaining a six-carbon backbone (tri-C6:0). Tri-C6:0 MCTs are absorbedvery rapidly by the gastrointestinal tract in a number of animal modelsystems. In another embodiment, the method comprises the use of MCTswherein R1, R2, and R3 are fatty acids containing an eight-carbonbackbone (tri-C8:0). In another embodiment, the method comprises the useof MCT wherein R1, R2, and R3 are fatty acids containing a ten-carbonbackbone (tri-C10:0). In another embodiment, the method comprises theuse of MCT wherein R1, R2, and R3 are a mixture of C8:0 and C10:0 fattyacids. In another embodiment, the method comprises the use of MCTwherein R1, R2 and R3 are a mixture of C6:0, C8:0, C10:0, and C12:0fatty acids.

In another embodiment, greater than 95% of R1, R2 and R3 carbon chainsof the MCT are 8 carbons in length. In yet another embodiment, the R1,R2, and R3 carbon chains are 6-carbon or 10-carbon chains. In anotherembodiment, 50% of the R1, R2 and R3 carbon chains of the MCT are 8carbons in length and about 50% of the R1, R2 and R3 carbon chains ofthe MCT are about 10 carbons in length. Additionally, utilization of MCTcan be increased by emulsification. Emulsification of lipids increasesthe surface area for action by lipases, resulting in more rapidhydrolysis and release of medium chain fatty acids (MCFA). Methods foremulsification of these triglycerides are well known to those skilled inthe art. Additional information about MCTs are provided in, for example,U.S. Pat. No. 8,124,589, which is hereby incorporated by reference itits entirety.

In another embodiment, the preferred short, medium and long chaintriglycerides may be isolated from natural or processed fats or oils, orfractions thereof using techniques known in the art.

“Designer” fats are also within the scope of the subject technology,what is essentially achieved is the formation of the fat component ofthe subject technology which maximize dietary and therapeutic efficacy.For example, the fat component of the compositions of the subjecttechnology can be solely an LCT or MCT or SCT, but substantially free ofthe other two types of triglycerides. Alternatively or in addition, thefat component can be a mixture of various LCTs or various MCTs orvarious SCTs. Alternatively or in addition, the fat component can be amixture of one or more LCTs and one or more MCTs, but substantially freeof SCTs. Alternatively or in addition, the fat component can be amixture of one or more LCTs and one or more SCTs but substantially freeof MCTs. Alternatively or in addition, the fat component can be amixture one or more MCTs and one or more SCTs but substantially free ofLCTs. Alternatively or in addition, the fat component can be a mixtureone or more LCT, one or more MCT and one or more SCT. Alternatively orin addition, the fat component can be any combinations of at least twoof LCT, MCT or SCT, wherein each triglyceride can in turn include asingle LCT, MCT or SCT or a mixture of LCTs, MCTs or SCTs.

In an embodiment, the effective amount of fat used in compositions andmethods of the subject technology is an amount that together with theprotein(s) of the composition induces weight loss in a subject. Asdiscussed herein above, such effective amount of fat can be determinedin light of blood ketone levels, urine ketone levels or weigh lossmeasurements. In certain embodiments, the ratio of fat to protein in thecompositions of the subject technology is in the range of about 0.05:1to about 1:1 by weight. In this context, a daily (24-hour) fat dose inthe composition is about 0.05 g/kg/day to about 3 g/kg/day. In otherembodiments, the fat daily dose is in the range of about 0.1 g/kg/day toabout 2.5 g/kg/day. In other embodiments, the daily dose of fat is atleast about 0.05 g/kg/day, at least about 0.1 g/kg/day, at least about0.15 g/kg/day, at least about 0.2 g/kg/day, at least about 0.5 g/kg/day,at least about 1 g/kg/day, at least about 1.5 g/kg/day, at least about 2g/kg/day, at least about 2.5 g/kg/day, at least about 3 g/kg/day, atleast about 4 g/kg/day, at least about 5 g/kg/day, at least about 10g/kg/day, at least about 15 g/kg/day, at least about 20 g/kg/day, atleast about 30 g/kg/day, at least about 40 g/kg/day, or at least about50 g/kg/day. In certain embodiments, a daily (24-hour) dose of thecomposition of the subject technology, for nasogastric administration,includes fat in a total amount of about 50 to about 150 grams, or anyspecific number within that range. In certain embodiments, the dailydose of fat is about 108-135 grams, or any specific number within thatrange.

In an embodiment, the effective amount of a fat (e.g., MCT) used incompositions and methods of the subject technology is an amount thattogether with the protein(s) of the composition synergistically inducesketosis and in turn weight loss in a subject. The ketosis occurs whenthe composition is administered to a subject as the only source ofnutrition for at least 12 hours. In a related embodiment, thecomposition further reduces or eliminates hunger for at least 12 hours.As discussed herein above, such effective amount of fat can bedetermined in light of blood ketone levels, urine ketone levels or weighloss measurements.

In an embodiment, the effective amount of fat (e.g., MCT) used incompositions and methods of the subject technology is an amount thattogether with the protein(s) of the composition synergistically reducesor eliminates hunger in a subject. This synergy occurs when thecomposition of the subject technology is administered to a subject asthe only source of nutrition for at least 12 hours. As discussed hereinabove, such effective amount of fat can be determined in light of hungerassessments using visual analogue scales (VAS) as described in Flint etal. (2000) or a variation thereof. In an embodiment, the daily fat doseis about 0.1 g/kg/day to about 1.5 g/kg/day.

In an embodiment, the weight loss composition of the subject technologyincludes an amount of fat, which can be at least, greater than, equalto, or any number in between 2%, 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%,45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, or 95% w/w or w/vfat). In another embodiment, the weight loss composition of the subjecttechnology provides a daily dosage of fat in an amount of about 10 to150 grams. Alternatively, the weight loss composition of the subjecttechnology provides a daily dosage of fat in an amount equal to orgreater than 5 grams, 7 grams, 10 grams, 20 grams, 30 grams, 40 grams,50 grams, 60 grams, 80 grams, 100 grams, 110 grams, 120 grams, 130grams, 140 grams or 150 grams, or any number in between. In anembodiment, the weight loss composition of the subject technologyprovides a daily dosage of fat in an amount of about 5-150 grams. In anembodiment, the weight loss composition of the subject technologyprovides a daily dosage of fat in an amount of about 10 grams. In anembodiment, the weight loss composition of the subject technologyprovides a daily dosage of fat in an amount of about 90 grams.

The compositions of the subject technology can be administered to asubject enterally. Preferably, the compositions are administeredorogastrically and/or nasogastrically via a feeding tube. In anembodiment, the weight loss compositions of the subject, technology areadministered continuously or intermittently. In an embodiment, thecomposition of the present disclosure is administered to a subject inneed thereof as the sole source of nutrition for a period of at least 12hours, at least one day (24 hrs), at least 3 days, at least 5 days, atleast 7 days or at least 9 days.

In an embodiment, the composition of the subject technology alsoincludes one or more vitamins and/or minerals. For example, sufficientvitamins and minerals may be provided to supply about 25% to about 250%of the recommended daily allowance of the vitamins and minerals per 1000calories of the nutritional composition. In addition, the compositionpreferably has an osmolarity of about 200 mOsm/1 to about 400 mOsm/1;for example about 250 mOsm/1 to about 350 mOsm/1.

In an embodiment, the composition of the subject technology is in theform of a ready-to-use formulation. In this form, the composition may befed to a patient via a nasogastric tube, jejunum tube or by having thepatient drink it. In an alternative embodiment, the composition is insoluble powder form for reconstitution prior to use.

In an embodiment, the formulations provide daily doses of thecompositions of the subject technology. In an embodiment, the subjecttechnology provides a formulation comprising a mixture of protein andfat to provide weight loss when administered to a subject as the onlysource of nutrition for a period of at least 12 hours. In a relatedembodiment, the formulation of the subject technology is substantiallyfree of carbohydrates. In certain embodiments, the ratio of fat toprotein in the formulations of the subject technology is in the range ofabout 0.05:1 to about 1:1 by weight. In an embodiment, this ratio isabout 0.1:1 by weight, about 0.15:1 by weight, about 0.25:1 by weight,about 0.35:1 by weight, about 0.45:1 by weight, about 0.55:1 by weight,about 0.65:1 by weight, about 0.75:1 by weight, about 0.85:1 by weight,or about 0.95:1 by weight.

In an embodiment, a formulation of the subject technology comprises arange of about 5 to about 150 g of emulsified fat combined with about100 to about 150 g of a protein. Amounts of fat can be at least about 5g, at least about 10 g, at least about 50 g or at least about 100 g.Amounts of protein can be at least about 50 g, at least about 100 g orat least about 150. For example, an exemplary daily dosage form of thesubject technology can contain 10 g MCT (99% triC8:0) emulsified with100 g of whey protein. Such a formulation is well tolerated andgenerally induces hyperketonemia for 3-4 hours in healthy humansubjects.

In certain embodiments, the composition of the subject technologyfurther includes one or more pharmaceutical compounds such asanti-bloating or anti-diarrheal agent. In certain other embodiments, thecomposition of the subject technology further includes pharmaceuticallyacceptable additives or diluents.

In an embodiment, the composition of the subject technology is producedaccording to a conventional method; for example, by blending togetherthe protein source and a fat source. Emulsifiers may be included in theblend. Vitamins and/or minerals may be added, but are usually addedlater to avoid thermal degradation. Lipophilic vitamins, emulsifiers orthe like may be dissolved into the lipid source prior to blending.Water, preferably water which has been subjected to reverse osmosis, maybe mixed in to form a liquid mixture. The temperature of the water canbe about 50° C. to about 80° C. to aid dispersal of the ingredients.Commercially available liquefiers may be used to form the liquidmixture.

The liquid mixture may be thermally treated to reduce bacterial loads.For example, the liquid mixture may be rapidly heated to a temperaturein the range of about 80° C. to about 110° C. for about 5 seconds toabout 5 minutes. This may be carried out by steam injection or by heatexchanger; for example a plate heat exchanger.

Preferably the liquid mixture is cooled to about 60° C. to about 85° C.;for example by flash cooling. The liquid mixture may be homogenised; forexample in two stages at about 7 MPa to about 40 MPa in the first stageand about 2 MPa to about 14 MPa in the second stage. The homogenisedmixture may be further cooled to add any heat sensitive components; suchas vitamins and minerals. The pH and/or solids content of thehomogenised mixture is conveniently standardized.

To produce a liquid product, the homogenised mixture is preferablyaseptically filled into suitable containers. Aseptic filling of thecontainers may be carried out by pre-heating the homogenised mixture(for example to about 75 to about 85° C.) and injecting steam into thehomogenised mixture to raise the temperature to about 140 to about 160°C.; for example at about 150° C. The homogenized mixture may be cooled,for example by flash cooling, to a temperature of about 75 to about 85°C. The homogenised mixture may be further homogenised, cooled to aboutroom temperature and filled into containers. Suitable apparatus forcarrying out aseptic filling of this nature is commercially available.To produce a powder product, the homogenised mixture is preferably driedto powder; for example by spray drying. Preferably, conventionalprocedures are used.

In an embodiment, the composition of the subject technology in liquidform is administered by tube feeding, by gravity, or pump. In this form,the composition may have a viscosity of less than about 12 cp at roomtemperature.

In an embodiment, the composition of the subject technology is suitablefor clinical use. Furthermore, the composition is preferably suitablefor patients with normal digestive function.

It will be appreciated that the composition may be in a form other thanthat suitable for clinical nutrition. For example, the composition maybe in the form of a dessert, cereal, yoghurt, snack bar, or the like. Iffed to pets, the enteral composition may be in the form of dried kibble,meat emulsion, or formulated emulsion.

While certain aspects and embodiments of the subject technology havebeen described, these have been presented by way of example only, andare not intended to limit the scope of the subject technology. Indeed,the novel methods and systems described herein may be embodied in avariety of other forms without departing from the spirit thereof. Theaccompanying claims and their equivalents are intended to cover suchforms or modifications as would fall within the scope and spirit of thesubject technology.

EXAMPLES

A better understanding of the subject technology may be obtained throughthe following examples which are set forth to illustrate, but are not tobe construed as the limit of the subject technology.

Example 1 Preparing the Patient for Insertion of the Nasogastric Tube

No fasting is necessary prior to insertion of the gastrointestinal tube.As a preliminary procedure, the patient's nostril that is clearer isidentified and sprayed with 2 sprays of phenylephrine 1%(Neo-Synephrine® Nose Spray). After at least 5 minutes, the patient isinstructed to rapidly “sniff” approximately 2.5 ml of lidocaine jelly 2%from a 3 ml syringe with no needle. The patient should feel thelidocaine jelly coat the entire nostril to the back of the throat andswallow the jelly. The lidocaine jelly is then allowed to anesthetizethe nasal mucosa, which could take at least 10 minutes.

Example 2 Insertion of the Gastrointestinal Tube

All necessary equipment should be prepared, assembled and available atthe bedside prior to insertion the gastrointestinal tube. Basicequipment includes: universal precautions; the gastrointestinal tubewhich should be flushed with 3 mL water before inserting the stylet; 2%lidocaine jelly; adhesive film such as Tegaderm®, stethoscope; cup ofwater with ice chips and straw; emesis basin available if needed.

For safety reasons, the patient is instructed to sit in a 90 degreesangel. The patient should hold a large cup of cold water with both handswith a straw in the mouth. Before insertion, the feeding tube is dippedin water to activate the lubricant and lidocaine jelly is applied to thetip. Slowly, the tube is inserted into the anesthetized nostril and intothe posterior nasopharynx. Occasionally, resistance may be encountereddue to the nasal turbinates. Gentle repositioning of the direction ofthe tube will overcome the obstruction. The patient must be asked torapidly swallow water as the tube is advancing into the esophagus. Thetube is advanced when the patient swallows. If the tube is advanced whenthe patient inhales, the tube may enter the larynx instead of theesophagus and cause coughing. The tube is continuously advanced as thepatient swallows water until the tube reaches the stomach or until about12-14 inches of the tube remains outside of the tip of the nose. Thepositioning of the tube in the patient stomach can be confirmed byinjecting 10 mL of air in the tube with a stethoscope over the stomach.The tube is then fastened to the cheek and passed behind the ear andagain fastened to the neck with transparent film dressing.

Example 3 Weight Loss Studies

This example relates to the effect of an exemplary composition of thesubject technology on body weight in a human subject.

An exemplary composition of the subject technology (See Table 2) isnasogastrically administered to a healthy female subject of 38 years ofage.

TABLE 2 A daily dosage formulation (to be reconstituted in 2 Liters ofwater) for 24 hrs nasogastric administration Component Amount % DailyValue Protein (whey protein isolate) 100-150 g Varies MCT (from coconutoil) 10-150 g Varies Vitamin A 5000 IU 100% Vitamin C 3 mg 100% VitaminD 4 mg 100% Vitamin E 40 mg 100% Vitamin B1 4 mg 100% Vitamin B2 800 mcg100% Niacin 12 mcg 100% Vitamin B6 60 mcg 100% Folic Acid 10 mg 100%Vitamin B12 3 mg 100% Biotin 4 mg 100% Pantothenic Acid 20 mg 100%Calcium 4 mg 2% Phosphorous 800 mcg 8% Potassium 12 mcg 2% Chloride 60mcg 2%

The composition above promoted a comparable or even greater body weightloss as compared to a diet that lacks MCTs. See Table 3 for the weightloss results in this subject.

TABLE 3 10-day weight loss test results URINE HUNGER DAY WEIGHT KETONES(0-4) 1 182 NEG 0 2 15 0 3 15 0 4 50 0 5 50 0 6 172 50 0 7 150 0 8 150 09 150 0 10 163 150 0

As shown in Table 3, the subject lost more than 10 percent of her bodyweight in 10 days.

Example 4 Hunger Studies

In a separate study, the effects of the compositions of the subjecttechnology on hunger sensation were tested. In this study, at threeseparate times (at least 12 hours apart), a human subject wasnasogastrically given three formulations listed in three columns shownbelow. See Table 4. The subject was not informed of the nature orcontents of each formulation but was asked to describe her hungersensation on a scale of 0-4 with zero being not hungry at all and 4being extremely hungry or as hungry as the subject had ever felt.

TABLE 4 Hunger Assessments Results THE K-E DIET FORMULA PROTEIN FORMULAONLY MCT OIL ONLY URINE HUNGER URINE HUNGER URINE HUNGER KETONES (0-4)KETONES (0-4) KETONES (0-4) DAY 1 NEG (after 6 0 NEG (after 6 3 NEG(after 6 4 hours of starting hours of starting) hours of starting) DAY 215 0 15 4 stopped due to extreme hunger DAY 3 50 0 15 3

As shown in Table 4, it was surprisingly found that the MCT and proteincomponents of the weight loss composition of the instant disclosure cansynergistically reduce and/or eliminate hunger throughout the treatmentperiod.

Example 5 Weigh Loss Studies

This example discloses the use of compositions and methods of thesubject technology for promoting weight loss in human subjects. In thisstudy, a daily (24-hour) dose of an exemplary composition of the subjecttechnology (the K-E diet) was nasogastrically administered to elevenhuman subjects for a period of 10 days. Weights of the subjects beforeand after the diet program were measured which are shown in Table 5below. The level of hunger was also determined in these individuals on adaily basis, whose average for each individual is provided in Table 5.

TABLE 5 The Weight Loss Results of the K-E Diet Being AdministeredNasogastrically Patient No. WT Before WT After WT Loss % Hunger 1 153138 15 10% 0 2 182 162 20 11% 0 3 242 218 24 10% 1 4 172 155 17 10% 1 5184 164 20 11% 0 6 164 148 16 10% 0 7 142 125 17 11% 0 8 195 172 23 12%0 9 205 183 22 10% 1 10 176 156 20 11% 0-1 11 227 202 25 11% 0

As indicated by the percent weight loss in these eleven subjects, theK-E diet on average results in weight loss of 1% per day or higher,which is significantly greater than that promoted by compositions thatlack MCTs.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious tables, it should be understood that these are for illustrationpurposes only and should not be taken as limiting the scope of thesubject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

Although the subject technology has been described with reference to theexamples provided above, it should be understood that variousmodifications can be made without departing from the spirit of thesubject technology.

What is claimed is:
 1. A method for treating a disorder or diseaseassociated with obesity or excess body weight in a patient in needthereof comprising administering to the patient a composition comprisingprotein and fat; wherein the composition comprises less than about 1.5%by weight carbohydrates and less than about 0.05% by weight long chaintriglycerides (LCT) and less than about 0.05% by weight short chaintriglycerides (SCT); wherein the fat and protein comprises a ratio of0.05:1 to 1:1 by weight medium chain triglycerides (MCT) to protein. 2.The method of claim 1, wherein the disorder or disease is selected fromdiabetes, metabolic syndrome and hypertriglyceridaemia.
 3. The method ofclaim 1, wherein the disorder or disease is metabolic syndrome.
 4. Themethod of claim 1, wherein the composition is in a liquid dosage formfor administration to a subject through a nasogastric feeding tube, anorogastric feeding tube or a jejunum tube.
 5. The method of claiml,wherein the composition provides a dosage of the protein in an amount offrom 60 to 150 g.
 6. The method of claim 1, wherein the compositionfurther comprises a component selected from the group consisting ofvitamins, minerals, essential amino acids, and combinations thereof. 7.The method of claim 1, wherein the composition is administeredcontinuously or intermittently throughout a course of treatment.
 8. Themethod of claim 1, wherein the MCT comprises at least one of a mediumchain triglyceride of the formula:

wherein the R1, R2, and R3 esterified to the glycerol backbone are eachindependently fatty acids comprising a 6-12 carbon chain.
 9. The methodof claim 8, wherein the MCT comprises at least one of caproictriglyceride, caprylic triglyceride, capric triglyceride or laurictriglyceride.
 10. A method for treating diabetes type II in a patient inneed thereof comprising administering to the patient a compositioncomprising protein and fat; wherein the composition comprises less thanabout 1.5% by weight carbohydrates and less than about 0.05% by weightlong chain triglycerides (LCT) and less than about 0.05% by weight shortchain triglycerides (SCT); wherein the fat and protein comprises a ratioof 0.05:1 to 1:1 by weight medium chain triglycerides (MCT) to protein.